Search FDA 510(k) Database

6,437 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8113–8136 of 174,061
Cleared Sep 08, 2023
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)...
K232426 · MBH
Conformis, Inc.
Orthopedic · 28d
Cleared Sep 08, 2023
Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
K232414 · JWH
Total Joint Othopedics, Inc.
Orthopedic · 29d
Cleared Sep 08, 2023
Fusion Robotic Navigation System
K232413 · OLO
Alphatec Spine, Inc.
Orthopedic · 29d
Cleared Sep 08, 2023
VariSeed (v10)
K232400 · MUJ
Varian Medical Systems
Radiology · 29d
Cleared Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with...
K232386 · NQQ
Abbott Medical
Cardiovascular · 30d
Cleared Sep 08, 2023
PreXion3D Expedition
K232166 · OAS
Prexion Corporation
Radiology · 49d
Cleared Sep 08, 2023
Sterile syringes for single use with/without needle
K231729 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Auto-Disable Syringes with/without Needle for Single Use
K231727 · FMF
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Safety Hypodermic Needles for Single Use
K231723 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Hypodermic Needles for Single Use
K231720 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231643 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 95d
Cleared Sep 08, 2023
Air/Water Bottle Tubing, CO2 Source Tubing
K231471 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 109d
Cleared Sep 08, 2023
Cleerly ISCHEMIA
K231335 · QXZ
Cleerly, Inc.
Cardiovascular · 123d
Cleared Sep 08, 2023
OnPoint Augmented Reality Spine System
K231284 · SBF
Onpoint Surgical, Inc.
Orthopedic · 128d
Cleared Sep 08, 2023
MaxTack™ Motorized Fixation Device
K231240 · OCW
Covidien
General & Plastic Surgery · 133d
Cleared Sep 08, 2023
AliTight
K231146 · GEI
Alic Iotech, LLC
General & Plastic Surgery · 140d
Cleared Sep 08, 2023
STarFix Designer Software C0265
K231141 · QRI
FHC, Inc.
Neurology · 140d
Cleared Sep 08, 2023
ISE Electrodes
K230890 · CEM
Randox Laboratories, Ltd.
Chemistry · 161d
Cleared Sep 08, 2023
Zeta Cranial Navigation System
K230661 · HAW
Zeta Surgical
Neurology · 182d
Cleared Sep 08, 2023
KARL STORZ Urological Laser Accessories
K230535 · GEX
Karl Storz SE & CO. KG
Gastroenterology & Urology · 193d
Cleared Sep 08, 2023
VitreJect Syringe
K230372 · QLY
Ocuject, LLC
General Hospital · 207d
Cleared Sep 08, 2023
STAT Medical Device Lancing System
K230310 · QRK
Stat Medical Devices
General & Plastic Surgery · 217d
Cleared Sep 08, 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848 · QUH
Tuned , Ltd.
Ear, Nose, Throat · 260d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 261d